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"Immediate Effect of DAFO on Gross Motor Function and Balance in Diplegic Cerebral Palsy

Key facts

Who runs it
Abant Izzet Baysal University
Where
Bolu, TürkiyeSee the site
Trial code
Status
Recruiting
People taking part
38 people, planned
Started
1 Apr 2024
Planned end
1 Dec 2025
Type of study
Observational
Treatments tested
  • "Assessment of Balance and Lower Extremity Gross Motor Function with and without DAFO"
Record updated
6 February 2025

Who can take part

Age
4 years to 15 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • Diagnosed with Spastic Diplegic type of cerebral palsy
  • Age between 4 and 15 years
  • Using bilateral Dynamic Ankle-Foot Orthosis (DAFO)
  • Communication Function Classification System (CFCS) level between 1 and 2
  • Gross Motor Function Classification System (GMFCS) level between 1 and 2
  • Willingness to participate in the study

Who cannot take part

  • Having experienced lower extremity fractures or muscle-tendon and bone surgery in the past 6 months, or having undergone spinal or orthopedic surgery affecting the lower extremities
  • Exposure to any pharmacological agent or intervention inhibiting spasticity in the past 6 months

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 4 and 15 years old?

Where in Türkiye

  • Bolu Abant Izzet Baysal UniversityBolu, TürkiyeContact: Seda AYAZ TAS, PhDTaking people

About the trial

What the trial wants to find out

" Study will investigate the immediate effect of DAFO usage on balance and gross motor functions in individuals with spastic diplegic cerebral palsy. The study is planned to be conducted with children aged 4-15 who have GMFCS levels 1 and 2 and who are willing to participate along with their families at the Turkey Spastic Children Foundation Metin Sabancı Special Education and Rehabilitation Center. During the dates of the study, children who meet the inclusion criteria will be evaluated. Demographic information such as age, height, and weight will be obtained for the participating children. To classify the gross motor levels of the children, the Gross Motor Function Classification System (GMFCS), the Manual Abilities Classification System (MACS) for hand skills, the Communication Function Classification System (CFCS) for communication skills, and the Eating and Drinking Ability Classification System (EDACS) for feeding skills will be used. In addition, the Gross Motor Function Measure (GMFM-88) items D and E for assessing motor skills, the Wii Balance Board for testing balance, the Pediatric Berg Balance Scale, and the functional reach test will be utilized. The balance and gross motor functions of the included children will be assessed in two different ways: with and without DAFO. Data analysis will be conducted by a blinded statistician who is not part of the research team. IBM SPSS 26 (Statistical Package for Social Sciences) will be used for statistical analysis of the data. Normality of continuous variables will be assessed using the Kolmogorov-Smirnov test. If continuous variables follow a normal (parametric) distribution, paired sample t-tests will be conducted on pre-test and post-test data. If the data are non-parametric, Wilcoxon test will be used. Pearson chi-square test or Spearman correlation coefficient will be used to determine the relationship between variables based on assumptions. Results will be evaluated at a significance level of p < 0.05 with a 95% confidence interval."

The group in the trial

  • Case Group

    "The Gross Motor Function Classification System (GMFCS) will be used to classify children's gross motor levels, the Manual Abilities Classification System (MACS) for hand skills, the Communication Function Classification System (CFCS) for communication skills, and the Eating and Drinking Ability Classification System (EDACS) for feeding skills. Additionally, the Gross Motor Function Measure (GMFM-88) items D and E will be used to assess motor skills, the Wii Balance Board for testing balance, the Pediatric Berg Balance Scale, and the functional reach test will be utilized. The balance and gross motor functions of the included children will be evaluated in two different ways: with and without DAFO."

    Treatment: "Assessment of Balance and Lower Extremity Gross Motor Function with and without DAFO"

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Examination of the Instant Effect of DAFO Use on Balance and Lower Extremity Gross Motor Functions in Individuals With Spastic Diplegic Cerebral Palsy
Fit questions
Built from NCT06343688, who can take part
Record updated
6 February 2025